Psilocybin for Healthy Subjects
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial will study how psilocybin, a substance from certain mushrooms, affects thoughts and brain activity in healthy volunteers. Researchers will use computer tasks, EEG, and MRI to measure these effects. Understanding these changes may help improve future treatments and our knowledge of consciousness. Psilocybin, a psychoactive alkaloid found in hallucinogenic mushrooms, has been historically used for ritualistic, recreational, and medicinal purposes, with recent scientific interest in its potential therapeutic effects.
Will I have to stop taking my current medications?
If you are currently taking psychoactive prescription medications or medications with a primary serotonergic effect regularly, you will need to stop taking them before participating. For 'as needed' medications, there is a required waiting period before the psilocybin sessions.
Is psilocybin safe for human use?
Psilocybin, found in magic mushrooms, can cause effects like hallucinations and changes in movement, but is generally considered relatively harmless when used in controlled settings. However, there are risks if poisonous mushrooms are mistakenly consumed, and caution is advised for people with heart conditions.12345
How is the drug psilocybin unique compared to other treatments?
Psilocybin is unique because it is a psychoactive compound found in 'magic mushrooms' that can induce hallucinogenic effects by rapidly affecting the central nervous system. Unlike traditional treatments, it is being studied for its potential to mediate beneficial health outcomes through the quality of the subjective experience it induces.16789
What data supports the effectiveness of the drug psilocybin for healthy subjects?
Research indicates that psilocybin, found in magic mushrooms, can produce unique experiences by affecting serotonin receptors in the brain, which may lead to beneficial health outcomes. Although primarily studied in palliative care, its psychoactive effects are being explored for potential therapeutic applications.1281011
Who Is on the Research Team?
Frederick S Barrett, PhD
Principal Investigator
Johns Hopkins University
Are You a Good Fit for This Trial?
Participants must be healthy adults aged 18-75, vaccinated against COVID-19, fluent in English with at least high school education. They should have prior experience with psychedelics and agree to avoid psychoactive substances and certain medications before sessions. Pregnant or nursing women, individuals with cardiovascular issues, epilepsy, diabetes on insulin, psychiatric disorders or those taking serotonergic medications are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either psilocybin or placebo in a double-blind, placebo-controlled, within-subject, full cross-over study
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Placebo
- Psilocybin
Psilocybin is already approved in United States, European Union for the following indications:
- Treatment-resistant depression (TRD) under Breakthrough Therapy designation
- Treatment-resistant depression (TRD) under PRIME designation
Find a Clinic Near You
Who Is Running the Clinical Trial?
Johns Hopkins University
Lead Sponsor